MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number	1012449-08
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimated.Evaluation summary: visual and functional analysis were performed on the returned device.The reported loose or intermittent connection was not confirmed; however, the device was returned with a hypotube separation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that may have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty or for the noted hypotube separation.There is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the connection of the indeflator came apart from the shaft of the 3.0 x 8 mm nc trek balloon dilatation catheter.Another balloon catheter was used to complete the procedure with no reported adverse patient effect or clinically significant delay.Device analysis revealed the hypotube was separated at the distal end of the hub.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8461968
• Report Number: 2024168-2019-02405
• Device Sequence Number: 2839731
• Product Code: LOX
• UDI-Device Identifier: 08717648151859
• UDI-Public: 08717648151859
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 1012449-08
• Device Lot Number: 81120G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1